Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1TAPI Technology & API Services
03 1Apotex Pharmachem
04 1Aurobindo Pharma Limited
05 1Chemi SpA
06 1Chongqing Shenghuaxi Pharma. Co., Ltd
07 1Emcure Pharmaceuticals
08 1Gador SA
09 1Macleods Pharmaceuticals Limited
10 2Natco Pharma
11 1Orchid Pharma
12 1Roche Diagnostics GmbH
13 1Sun Pharmaceutical Industries Limited
01 1IBANDRONATE MONOSODIUM MONOHYDRATE
02 3IBANDRONATE SODIUM
03 1IBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE)
04 4IBANDRONATE SODIUM MONOHYDRATE
05 1IBANDRONATE SODIUM MONOHYDRATE (INJECTABLE GRADE)
06 1IBANDRONATE, EDITION I
07 2SODIUM IBANDRONATE
08 1SODIUM IBANDRONATE MONOHYDRATE
01 1Argentina
02 1Canada
03 1China
04 1Germany
05 7India
06 1Israel
07 1Italy
08 1Poland
01 11Active
02 3Inactive
01 4Complete
02 10Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-12
Pay. Date : 2016-06-21
DMF Number : 25638
Submission : 2011-12-29
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20494
Submission : 2007-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20525
Submission : 2007-05-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-01-04
DMF Number : 20393
Submission : 2007-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20427
Submission : 2007-04-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20391
Submission : 2007-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-10
Pay. Date : 2013-07-23
DMF Number : 24824
Submission : 2011-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20411
Submission : 2007-04-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20422
Submission : 2007-04-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20605
Submission : 2007-06-06
Status : Active
Type : II
A Ibandronate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibandronate Sodium, including repackagers and relabelers. The FDA regulates Ibandronate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibandronate Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ibandronate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibandronate Sodium supplier is an individual or a company that provides Ibandronate Sodium active pharmaceutical ingredient (API) or Ibandronate Sodium finished formulations upon request. The Ibandronate Sodium suppliers may include Ibandronate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Ibandronate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ibandronate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibandronate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Ibandronate Sodium DMFs exist exist since differing nations have different regulations, such as Ibandronate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibandronate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Ibandronate Sodium USDMF includes data on Ibandronate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibandronate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibandronate Sodium suppliers with USDMF on PharmaCompass.
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